Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis A; Hepatitis B

Treatments: Biological: Twinrix™ Adult; Biological: Twinrix™ Junior

Study type: Interventional

Funder types: Industry

Identifiers

NCT00197184

208127/133 (EXT Y3) (Other Identifier)

208127/137 (EXT Y5) (Other Identifier)

208127/132 (EXT Y2)

208127/134 (EXT Y4) (Other Identifier)

Details and patient eligibility

About

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full description

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Enrollment: 276 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participation in primary study
• Written informed consent obtained before each long term follow up visit.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Twinrix Junior

Experimental group

Description:

Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).

Treatment:

Biological: Twinrix™ Junior

Twinrix Adult

Active Comparator group

Description:

Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).

Treatment:

Biological: Twinrix™ Adult